Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Difference in mean daily reflective Total Nasal Symptom Score (rTNSS) between treatment groups
研究概览
简要总结
This study is designed to evaluate the efficacy, safety, and tolerability of PL-14 Allergy Blocker compared to saline spray in adults with Seasonal Allergic Rhinitis (SAR).
PL-14 Allergy Blocker is a non-pharmacological, drug-free intranasal mucoadhesive hydrogel designed to form a mechanical barrier on the nasal mucosa and reduce contact between airborne allergens and the nasal lining.
This is a prospective, randomized, single-blind, multi-center clinical investigation in up to 120 participants at up to 8 sites in the United States. Eligible participants with a history of seasonal allergic rhinitis will be randomized in a 1:1 ratio to receive either PL-14 Allergy Blocker or Ayr® Saline Nasal Mist for up to 30 days.
The study will evaluate the effect of PL-14 Allergy Blocker on nasal allergy symptoms, quality of life, rescue medication use, and symptom-free days. Safety and local tolerability assessments will also be performed throughout this study period.
详细描述
Seasonal Allergic Rhinitis (SAR) is a common chronic condition associated with symptoms such as sneezing, rhinorrhea, nasal congestion, and nasal itching triggered by exposure to airborne allergens. PL-14 Allergy Blocker is a non-pharmacological, drug-free intranasal mucoadhesive hydrogel designed to act purely as a mechanical barrier in the nasal cavity, significantly reducing contact between inhaled allergens and the nasal mucosa. PL-14 Allergy Blocker is intended to treat hay fever and allergy sufferers by promoting the alleviation of mild allergic symptoms, including itchy, runny, or congested nasal passages, triggered by the inhalation of various airborne allergens including indoor and outdoor environmental pollens, house dust, animal hairs, and dust mites. PL-14 Allergy Blocker functions by forming a non-specific, soft gel-like physical barrier on the nasal mucosa through the rheological and mucoadhesive properties of its primary components, sodium alginate and carrageenan. Upon application, PL-14 Allergy Blocker facilitates the formation of a continuous film that adheres to the nasal cavity and entraps inhaled particles, thereby reducing exposure of the nasal epithelium to airborne allergens. This study is a prospective, randomized, single-blind, saline-controlled, parallel-group, multi-center clinical investigation evaluating the efficacy, safety, and tolerability of PL-14 Allergy Blocker compared to Ayr® Saline Nasal Mist in adults with Seasonal Allergic Rhinitis. Up to 120 participants will be enrolled at up to 8 investigational sites in the United States. Eligible participants will undergo a treatment-free run-in period followed by randomization in a 1:1 ratio to either PL-14 Allergy Blocker or saline spray. Participants will self-administer the assigned study product for up to 30 days. Efficacy assessments will primarily focus on the first 14 treatment days and will include reflective and instantaneous Total Nasal Symptom Scores (rTNSS/iTNSS), quality of life assessments using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), rescue medication use, and symptom-free days. Safety assessments will include adverse events monitoring, local nasal tolerability evaluations, nasal examinations, concomitant medication assessments, and investigator and participant global tolerability assessments throughout the study period. The total participation duration for each subject will be approximately 37 days, including screening, treatment, and follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical history of seasonal AR, as reported by the subject, with symptoms for more than two years and exacerbations during the study season for the relevant seasonal allergen (e.g., tree/grass pollen/ragweed).
- •Positive skin prick test (i.e., wheal ≥3 mm larger than the diluent control with erythema) or positive in vitro tests for specific IgE against allergen(s) relevant to the enrollment period at Baseline or within 12 months before enrollment .
- •Age ≥ 18 years and ≤ 75 years at Screening.
- •Active symptoms of seasonal AR with an rTNSS score ≥5 at randomization (based on the average rTNSS score during the Run-in Period and rounded to the nearest whole number).
- •Willing and able to complete a 7-consecutive-day washout prior to the Baseline/Randomization visit, during which the subject will abstain from:
- •(1) oral or systemic H1 antihistamines, (2) topical antiallergic treatment, (3) nasal vasoconstrictors (Intermittent use of Astepro Allergy - Antihistamine (azelastine) nasal spray as rescue medication is allowed during the trial).
- •6. Females must be non-pregnant and non-lactating, and at least one of the following must apply: i) not a woman of childbearing potential (WOCBP) (post-menopausal for ≥ 12 months and confirmed through testing of FSH levels ≥ 40 IU/L at Screening Visit); ii) WOCBP using a contraceptive method that is highly effective (a low user-dependency method OR a user-dependent method in combination with barrier method) (plus: negative urine pregnancy test and Screening Visit, within 24 hours before the first dose of study intervention and willing to have additional pregnancy tests as required throughout the study ; iii) WOCBP abstinent from sexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) for 28 days from the start of study intervention.
- •7. Willing and able to attend all trial visits.
- •Able to read and understand study documents and follow instructions from the Investigator and study personnel during visits.
- •9. Signed IRB/EC-approved informed consent form obtained prior to any study-related procedures.
排除标准
- •1. Presence of active, moderate or severe symptoms of non-allergic rhinitis , acute inflammation of the nose, or paranasal sinusitis at Screening or within the 7 days prior.
- •2. Positive rapid-result COVID-19 antigen test.
- •Uncontrolled asthma under treatment with any medication other than inhaled short-acting beta-2 agonists, or with known FEV1 < 70% within the previous 6 months.
- •4. Diagnosis or symptoms of acute respiratory infection at Screening or within the previous 4 weeks.
- •5. Vaccinations: i) live vaccine(s) within 1 month prior to Screening or planned during the study; ii) killed vaccine within 1 week prior to Screening; iii) planned COVID-19 vaccine from Day -7 through Day
- •6. Nasal or paranasal sinus surgery within the previous 8 weeks.
- •Long-term continuous use of inhaled or intranasal glucocorticosteroids (intermittent use is allowed).
- •8. Initiation of allergen immunotherapy within 3 months prior to Screening, or failure to have reached the maintenance phase of allergen immunotherapy at the time of enrollment, or any change in allergen immunotherapy dose or regimen within 1 month prior to Screening.
- •9. Treatment with leukotriene receptor antagonists (at Screening or within 1 week prior) or regular/chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs) at screening or within 1 week prior. Intermittent NSAID use as relief/rescue medication is allowed.
- •10. Known hypersensitivity to any constituent of the study devices (test & control) .
- •11. Clinically significant nasal abnormalities that may interfere with proper device administration or affect nasal airflow, including but not limited to:
- •Nasal septal deviation associated with clinically significant nasal obstruction, as determined by the investigator based on physical examination, and resulting in functional impairment (e.g., patient-reported difficulty in airflow).
- •Nasal polyps
- •Chronic rhinosinusitis (with or without nasal polyposis)
- •Turbinate hypertrophy of clinical significance
- •History of nasal surgery within the past 6 months
- •Structural abnormalities (e.g., perforated septum, severe nasal valve collapse)
- •Active nasal infection or acute sinusitis Subjects presenting with any of these conditions will be excluded from participation.
- •12. Any clinically relevant autoimmune, respiratory (especially with reduction of respiratory capacity) or cardiovascular disease, malignant tumors, bleeding disorders, autoimmune diseases, neurological disorders, or any other abnormality that, in the opinion of the Investigator, may pose a safety risk, confound the clinical performance or safety assessment, or interfere with study participation.
- •13. Concurrent participation in another clinical study or participation in another clinical study within 30 days prior to Screening.
- •14. A history of alcohol or drug abuse, within 2 years prior to screening, or current use of recreational drugs (particularly intranasal).
- •15. Planned travel to a region outside the designated pollen area for the Clinical Research Unit (CRU), as defined in the informed consent form, for ≥24 hours during the 7-day Run-in Period, OR for ≥2 consecutive days or a total of ≥3 days between the randomization visit and the follow-up phone call
研究组 & 干预措施
PL-14 Allergy Blocker
Participants assigned to this arm will self-administer PL-14 Allergy Blocker intranasally for up to 30 days according to the study Instructions for Use.
干预措施: PL-14 Allergy Blocker (Device)
Ayr® Saline Nasal Mist
Participants assigned to this arm will self-administer Ayr® Saline Nasal Mist intranasally for up to 30 days according to the manufacturer Instructions for Use.
干预措施: Ayr® Saline Nasal Mist (Device)
结局指标
主要结局
Difference in mean daily reflective Total Nasal Symptom Score (rTNSS) between treatment groups
时间窗: 14 treatment days
Assessment of the difference in mean daily reflective Total Nasal Symptom Score (rTNSS) between PL-14 Allergy Blocker and Ayr® Saline Nasal Mist during the first 14 treatment days.
次要结局
未报告次要终点